BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 22559450 · Received July 21, 2025

    Report

    Report Number
    3003768277-2025-006678
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    July 14, 2025
    Report Date
    September 9, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K162859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. IT WAS REPORTED TO PHILIPS THAT THE SYSTEM POWER UP FAILED. REVIEW OF THE LOGFILE SHOWS NO CONTROL NETWORK CONNECTION IPPC. REVIEW OF THE LOGFILES SHOWS THE FRONT PANEL FAILED, AND THE SYSTEM CAN¿T POWER UP. REVIEW OF THE LOGFILE SHOWS THE FRONT PANEL FAILED, AND THE SYSTEM CAN¿T POWER UP. UPON TROUBLESHOOTING, THE PHILIPS FIELD SERVICE ENGINEER (FSE) CHECKED THE SYSTEM ONSITE AND FOUND THE PDU FRONT PANEL LED ON THE M CABINET REMAINED OFF AT ALL TIMES AND FSE RAN DIAGNOSTIC SOFTWARE AND FOUND A FAILURE IN THE PDU FRONT PANEL PCM. TO RESOLVE THE ISSUE, THE FSE REPLACED THE PDU FRONT PANEL. AFTER REPLACEMENT, THE SYSTEM RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WAS UNABLE TO POWER UP. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737537 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20/10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown